The Access Total IgE Calibrators are intended to calibrate the Access Total IgE assay for the quantitative determination of total IgE levels in human serum and plasma (heparin, EDTA) using the Access Immunoassay Systems.

The Access Total IgE Calibrators are intended to calibrate the Access Total IgE assay for the quantitative determination of total IgE levels in human serum and plasma (heparin, EDTA) using the Access Immunoassay Systems.
Access Total IgE Calibrators - 35005

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin E (IgE total) in a clinical specimen, using a chemiluminescent immunoassay method.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DGC

Device Name: Ige, Antigen, Antiserum, Control

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: IM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.5510

Third Party Flag: Y

Medical Specialty: IM

Device Id: 15099590221317

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A